Hypotension Postprocedural, Pregnancy, Spinal Anesthesia
Conditions
Keywords
Hypotension, Cesarean Section, Spinal Anesthesia, Shock Index
Brief summary
This prospective observational study aims to evaluate the predictive performance of preoperative Shock Index (SI) and Modified Shock Index (MSI) for hypotension following spinal anesthesia in elective cesarean surgery. Post-spinal hypotension is a common complication that can affect maternal and fetal outcomes, and early identification of at-risk patients is essential for effective perioperative management.
Detailed description
This prospective observational study aims to evaluate the predictive performance of preoperative Shock Index (SI) and Modified Shock Index (MSI) for hypotension following spinal anesthesia in elective cesarean surgery. Post-spinal hypotension is a common complication that can affect maternal and fetal outcomes, and early identification of at-risk patients is essential for effective perioperative management. Eligible pregnant women scheduled for elective cesarean surgery under spinal anesthesia will be assessed preoperatively for SI and MSI. Blood pressure and hemodynamic parameters will be monitored throughout the perioperative period to identify the occurrence and severity of hypotension. The study will analyze the ability of SI and MSI to predict hypotensive events and determine optimal cutoff values for clinical use. The findings of this study may provide evidence to improve perioperative risk stratification, guide preventive interventions, and enhance maternal and fetal safety during elective cesarean surgery.
Interventions
None listed
Sponsors
Marmara University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years old * ASA II-III patients undergoing elective cesarean section
Exclusion criteria
* ASA IV patients * Patients with known neurologic or psychiatric disorders * Patients with clinically significant cardiovascular, respiratory, hepatic, renal or metabolic disease * Patients with alcohol or drug addiction * Mentally disabled patients * Patients with BMI\>30 * Patients who develop massive bleeding or coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predictive performances of preoperative shock indexes for intraoperative hypotension | From induction of spinal anesthesia until end of surgery | The ability of preoperative SI and MSI to predict intraoperative hypotension will be evaluated using receiver operating characteristic (ROC) analysis; area under the curve (AUC), sensitivity, specificity, and optimal cutoff values will be reported. SI is calculated as heart rate ÷ systolic blood pressure (HR/SBP); MSI is calculated as heart rate ÷ mean arterial pressure (HR/MAP). Hypotension is defined as a decrease of SBP to \<80% of baseline or SBP \<100 mmHg, or MAP \<80% of baseline or MAP \<65 mmHg. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative hypotension | From induction of spinal anesthesia until end of surgery (intraoperative period) | Proportion of patients meeting the predefined hypotension criteria during the intraoperative period. |
| Requirement for vasopressor treatment (ephedrine) | From induction of spinal anesthesia until end of surgery | Proportion of patients who receive any vasopressor for hypotension and total number treated. |
| Classification into hypotension vs. no-hypotension groups for comparison analyses | Intraoperative period | Number and proportion of patients classified as having developed hypotension vs not; used for subgroup analyses of baseline SI/MSI and outcomes. |
Countries
Turkey (Türkiye)
Contacts
CONTACTBeliz Bilgili
CONTACTBeyza Betül Özkurt
Outcome results
None listed